Condition category
Circulatory System
Date applied
23/10/2014
Date assigned
23/10/2014
Last edited
16/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cognitive problems, including in attention and working memory, are common consequences of a stroke. Studies have suggested that progressive computerized training (i.e. training exercises that become more challenging as performance improves) can enhance cognitive function not simply on the exercises that people have practiced, but more generally.

Who can participate?
People aged over 18 who have had a stroke

What does the study involve?
Participants are randomly allocated to one of three groups: home-based online working memory training, a similar training programme focused on attention skills, or a waiting list control group. All participants are first assessed on a range of cognitive tasks and questionnaires about everyday function. These assessments are repeated after the 4 weeks of training and again at a 3-month follow-up. Participants in the training groups are asked to try to complete 20 minutes per working day over the 4 weeks. Participants in the waiting list control group are allocated to one of the active training programmes after the follow-up. In addition to the relative effectiveness of the training programmes, this study examines the feasibility of recruiting participants, the acceptability of the interventions to participants, and other factors that will inform a larger study if the results are positive.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
MRC Cognition and Brain Sciences Unit (UK)

When is the study starting and how long is it expected to run for?
November 2014 to September 2017

Who is funding the study?
Stroke Association (UK)

Who is the main contact?
Dr Polly Peers
polly.peers@mrc-cbu.cam.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Polly Peers

ORCID ID

Contact details

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
-
polly.peers@mrc-cbu.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17621

Study information

Scientific title

Progressive home-based working memory and attention training following stroke, implications for spatial bias: a preliminary study

Acronym

Study hypothesis

In addition to the relative efficacy of the training programmes compared with the waiting list condition, the study will examine the feasibility of recruitment, the acceptability of the interventions to participants and other factors that will inform a definitive trial if the results are positive.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=17621

Ethics approval

14/EE/0149

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type

Intervention

In this study we aim to recruit people who have had a stroke and randomly allocate them to one of three conditions: home-based online working memory training, a similar training programme focused on attention skills; or a waiting list control group. All participants will be first assessed on a range of cognitive tasks and questionnaires about everyday function. These assessments will be repeated after the 4 weeks of training/waiting list and again at a 3 month follow-up. Participants in the training groups will be asked to try to complete 20 minutes per working day (MonFri) over the 4 weeks. Participants in the waiting list study will be allocated to one of the active training conditions after the followup.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Spatial Bias measure derived from Theory of Visual Attention paradigm

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2014

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years old
2. Able to give informed consent
3. Ability to interact with the computer with either hand or via the mouse

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Medical problems likely to prevent participation
2. Language problems likely to prevent comprehension of consent or the training instructions.

Recruitment start date

01/11/2014

Recruitment end date

01/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Cognition and Brain Sciences Unit
Cambridge
CB2 7EF
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Charity

Funder name

Stroke Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/02/2016: Plain English summary added.